Frequency Needed for School-based Obesity Intervention
Primary Purpose
Obesity, Child
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
School-Based Obesity Intervention (FLOW)
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Child
Eligibility Criteria
Inclusion Criteria:
- BMI-for-age (Body Mass Index) percentile ≥ 85
- Male or female between ages 10 - 17 years
- Self-identified as Mexican-American
Exclusion Criteria:
- Student who is pregnant, planning to become pregnant, or becomes pregnant
- School report of cognitive impairment significantly below average age and/or grade level
- Use of any weight-loss medication (prescription or nonprescription) for at least 6 months prior to screening
- Type 1 or 2 diabetes medical diagnosis
Sites / Locations
- YES Prep Brays Oaks
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
Control, 0 days
1 day
3 days
5 days
Arm Description
control group, no intervention
received the intervention 1 day/week
received the intervention 3 days/week
received the intervention 5 days/week
Outcomes
Primary Outcome Measures
Change in Standardized Body Mass Index (zBMI)
standardized body mass index
Secondary Outcome Measures
Full Information
NCT ID
NCT03797105
First Posted
January 4, 2019
Last Updated
January 7, 2019
Sponsor
University of Houston
Collaborators
Baylor College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03797105
Brief Title
Frequency Needed for School-based Obesity Intervention
Official Title
Frequency of Intervention Needed to Improve Weight Outcomes of Mexican-American Adolescents With Overweight or Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2012 (Actual)
Primary Completion Date
September 30, 2014 (Actual)
Study Completion Date
September 30, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston
Collaborators
Baylor College of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This randomized controlled trial compared changes in Mexican-American, adolescent standardized body mass index (zBMI) from a school-based obesity intervention given zero, one, three, or five days a week.
Detailed Description
Efficacious school-based interventions have been intensive making it difficult for interventions to be scaled. The more components there are to an intervention, typically the better the results. Instead of decreasing intensity via the removal of intervention components, this randomized controlled trial aimed to compare changes in Mexican-American adolescent standardized body mass index (zBMI) based on the number of days per week they received a multi-component intervention. Mexican-American middle school students (n=203) with overweight or obesity were recruited from an independent school district in Houston. Students were randomized to receive an obesity intervention with established efficacy zero (control), one, three, or five days/week. In each condition, 80% of intervention time was allocated to physical activity and 20% to nutrition. Directly measured height and weight were used to calculate zBMI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Child
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
243 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control, 0 days
Arm Type
No Intervention
Arm Description
control group, no intervention
Arm Title
1 day
Arm Type
Experimental
Arm Description
received the intervention 1 day/week
Arm Title
3 days
Arm Type
Experimental
Arm Description
received the intervention 3 days/week
Arm Title
5 days
Arm Type
Experimental
Arm Description
received the intervention 5 days/week
Intervention Type
Behavioral
Intervention Name(s)
School-Based Obesity Intervention (FLOW)
Intervention Description
The intervention consisted of nutrition lessons based on the traffic light diet, circuit-based physical activity, behavior modification techniques (token economy system, goal setting, self-monitoring), and parental involvement (materials sent home and monthly parent meetings). 80% of time was spent on physical activity and 20% was spent on nutrition. Behavior modification was incorporated into both physical activity and nutrition time. Specifically, instruction and activity time during PE class lasted approximately 40 minutes.
Primary Outcome Measure Information:
Title
Change in Standardized Body Mass Index (zBMI)
Description
standardized body mass index
Time Frame
baseline, 6, and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI-for-age (Body Mass Index) percentile ≥ 85
Male or female between ages 10 - 17 years
Self-identified as Mexican-American
Exclusion Criteria:
Student who is pregnant, planning to become pregnant, or becomes pregnant
School report of cognitive impairment significantly below average age and/or grade level
Use of any weight-loss medication (prescription or nonprescription) for at least 6 months prior to screening
Type 1 or 2 diabetes medical diagnosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig A Johnston, PhD
Organizational Affiliation
University of Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
YES Prep Brays Oaks
City
Houston
State/Province
Texas
ZIP/Postal Code
77031
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make IPD available to other researchers
Learn more about this trial
Frequency Needed for School-based Obesity Intervention
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